Biosimilars in Developing Countries: Key Issues

1. Biosimilars in Developing Countries: Key Issues Dr. Brian W Tempest www.briantempest.com Ad Hoc Expert Group Meeting UNCTAD, Geneva, Switzerland 21 January 2015

2. Dr Brian Tempest advises Companies, Banks, High Net Worth Individuals and Investment Funds on their Strategy in the Emerging World based on his wide experience in China, Japan, South East Asia and India where he has lived for the last decade. Brian is the Editor of the prestigious Journal of Generic Medicines. Previously he worked for Ranbaxy Laboratories since 1995 holding the position of Managing Director and Chief Executive Officer until 2005. He was then Chief Mentor and Non Executive Director until 2008 when he retired. He is one of the few westerners to have led a Sensex Nifty 50 Indian blue Chip MNC and as a result has a valuable insight into India. Brian has also worked for Glaxo as Regional Director Far East and Regional Director Middle East & Africa from 1985 to 1992. Brian has worked in the Pharmaceutical Industry for the last 44 years and has managed Healthcare businesses in North America, South America, Europe, Africa, Middle East, Australasia, China, Japan and India. He has also led many sessions at Investor Meetings held around the world from Tokyo to Las Vegas. He is now a Non Executive Director of Religare Capital Markets, Fortis Healthcare , SRL Diagnostics and Glenmark Pharmaceuticals. He is a member of the SCRIP Global awards panel. Brian speaks at global conferences and more information on these presentations can be found on his website www.briantempest.com. He is also an international advisor to UNCTAD and MAPE Brian has a PhD in Polymer Chemistry from Lancaster University in 1971 and in 2009 he became Chairman of the Advisory Board for the Lancaster University Management School, UK. He is a Fellow of the Royal Society of Medicine and a Fellow of the Royal Society of Chemistry and is a Chartered Chemist. He is also Executive Chairman of Hale & Tempest Co Ltd

3. Biosimilars Which Way?

4. Sanofi R&D - 72% Biologics & 50% mAbssource: Pharma Times 15 January 2015

5. Biosimilar Share to 2018source: EvaluatePharma 2012

6. Biologics in 2016Source: Cowen

7. Medicines getting More Expensive - USAsource: Evaluate 2014

8. USA Most Expensive Medicinessource: Evaluate 2014

9. Top 5 Approved Drugs in H1 - 40% mAbssource: Evaluate 2014

10. USA BTD 2013source: Evaluate 2014, 7 nibs, 3 mAbs out of 33

11. Top 10 Biologics in 2013 $68bsource: Evaluate 2014

12. Big Pharma Profit Margins from Biologicssource: Fiscal Year 2011 Roche 2014

13. India Disease Profilesource: Planning Commission India, Gyan Research 2014

14. Monoclonal Antibodies Complexitysource: Roche 2014

15. Three Waves of Biosimilarssource: SG EGA conference 2013

16. Biosimilars EU PatentsSource:

17. EU SPCs ending each month for mAbssource: Generics Bulletin 8 August 2014

18. 12 year data exclusivity in USAsource: An Outlook on US Biosimilar Competition, 2014

19. Patents on Global Biologic Salessource: Biosimilars: A guide to Regulatory & IP Issues Jan 2015

20. Biosimilar Challenges for USA Approvalsource: Roche 2014

21. Biosimilar Regulatory Pathwayssource: Roche 2014

22. Volume Effect from Biosimilarssource: IMS December 2011

23. Biosimilar Uptake in Europesource: Roche 2014

24. Biosimilars & Big Pharmasource: Pfizer presentation January 2015

25. Biosimilar Global Sales vs Forecastsource: Roche 2014

26. Global Biosimilarssource: Edelweiss 2014

27. Biosimilar Leading Companiessource: Novartis 2014

28. 700 Biosimilars under Developmentsource: PharmaTimes 30 September 2014

29. Sandoz Business Modelsource: Pharmacloud June 2012

30. Celltrion Manufacturing Facilitysource: Celltrion website, 140,000L expanding to 230,000L capacity

31. India R&D Expenses as % Salessource: Edelweiss 2014

32. India Biologicssource: Edelweiss 2014

33. Biosimilars 1% of DRL Salessource: Edelweiss Research 2014

34. DRL Biosimilar Regulatory Challengessource: Roche 2014

35. First Herceptin Trastuzumab Biosimilarsource: ET January 14 2014 Rs 40,000 per 440mg vial, Roche halved price at Rs 55,000

36. Licensed in from USAsource: Biopharma Reporter 3 Dec 2014

37. Biosimilar Alliances – to share the risk • Serum Institute & NeuClone • Richter & Stada – mAbs • Celltrion, Korea -Hospira, Egis, Hikma, BB, etc • Biocon & Mylan, USA, mAbs • Teva & Lonza, EU – dissolved July 2013 • Biocon Idec+Samsung, Japan - now Merck US • Actavis/Watson & Amgen, USA • Fuji Film & Kyowa Hakko Kirin • DRL & Merck-Serono, Germany - mAbs • Bionovis (Brazil) & Merck Serono

38. Biosimilar Alliancessource: Roche 2014

39. nibs (tyrosine kinase inhibitors) - small molecules which may replace mAbs • Axitinib, Pfizer; Cediranib, AZ - cancer • Pazopanib, GSK; Regorafenib, Bayer - cancer • Sorafenib, Bayer(Nexavar) -cancer • Sunitinib, Pfizer; Toceranib, Pfizer - cancer • Vandetanib, AZ; Semaxanaib, Sugen - cancer • Crizotinib (Xalkori) Pfizer, lung cancer, 2013 sales $0.3b with growth >100% • Tofactinib, Pfizer, RA

40. Bayer Commentssource: February 2 2014 Bayer

41. Strengths of Manufacturing Biosimilars in Developing Countries • Huge Savings • In 2016 11 out of top 20 pharma products will be biologics

42. Weaknesses of Manufacturing Biosimilar in Developing Countries • Up front investment between $100m and $200m • It takes many years before the products will be available • Existing pharmaceutical manufacturing assets are unlikely to be relevant • It is unfortunate that there is a variation in the nomenclature and regulatory pathway around the world. Biosimilars are sufficiently complex without these extra burdens

43. Opportunities of Manufacturing Biosimilars in Developing Countries • Will allow independence of other countries for their complex medicines • Once in the monoclonal segment other monoclonal antibodies will be available • Substitution by the pharmacist should be allowed by local laws • Timelines for development are so long that most patents will have expired by the time biosimilars are ready

44. Threats of Manufacturing Biosimilars in Developing Countries • 12 year rate of return with huge investment • Innovator companies are very protective • Many global alliances between many companies - a single country model difficult • Many products not in public area so there will be greater competition than expected • Branded products in developing countries need a team of salesmen • Doctors don’t like changing ill patients over • Price cuts could be large

45. Some Recommendations for Developing Countries considering Biosimilars • Regulatory pathways - use working pathways • Manufacturing may be based on regional clusters, government agencies or PPP • Product substitution by pharmacists allowed • Financial incentives should be offered instead of direct shareholding • Accept that prices will not fall below a certain level • Nomenclatures of biosimilars should be same

46. Thank You brian.tempest@clara.co.uk www.briantempest.com